Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients

Completed

• Conditions: HIV Infection
• Interventions: Procedure: colonoscopy with endoscopic biopsies

• Registration Number: NCT01679067
• Lead Sponsor: Clara Lehmann

Brief Summary

To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more likely to be diagnosed with opportunistic infections, their risk of death is higher and their rate of immunological improvement is slower (Mussini C et al., 2008). These patients often present a real challenge due to their advanced clinical status (Borghi V et al., 2008). Unfortunately, little is known about the clinical presentation of these patients, their responses to antiretroviral treatment and especially about the changes in the adaptive and innate immunity of the GALT.

Detailed Description

The investigator proposes to evaluate the virological, immunological and clinical outcomes of ART in HIV-1 infected 'late presenters'. The investigator further wants to investigate the longitudinal dynamics of the innate and adaptive immunity restoration in the GALT and peripheral blood of HIV infected patients under ART. In particular the investigators want to longitudinally assess DCs, NK-cells, CD4+ T-cells und CD45RO+-T-cells as well as the levels of IFNγ, IFNα, TNFα, and IL-12 in the GALT and peripheral blood by flow cytometry and by real-time PCR and correlate these data with laboratory and clinical parameters.

The investigators expect that this longitudinal study and experiments outlined in the protocol will provide valuable information about several important issues of the clinical outcome of patients under ART as well as understanding immunopathology during HIV-infection.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-08-31
• Study First Submitted QC: 2012-08-31
• Study First Posted: 2012-09-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Documented HIV infection
• Patients naive to antiretroviral treatment
• Age older than 18 years
• Indication for initiation of ART
• Informed consent

Exclusion Criteria

• Patients on antiretroviral treatment
• No informed consent
• Estimated life expectancy <1 year
• Age <18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-GALT	colonoscopy with endoscopic biopsies	-

Primary Outcome Measures

Name	Time	Method
restoration of CD4 + T-cells in the GALT with ART	6 months

Secondary Outcome Measures

Name	Time	Method
Function of Dendritic Cells (DC) in the GALT with ART	6 months	Functional characterization of DCs (IFNγ, IFNα) of DCs in the GALT
Functional characterization of NK-cells in the GALT with ART	6 months	Functional characterization on NK- cells (TNFα, and IL-12) in the GALT with ART

Trial Locations

Locations (1)

University of Cologne; 🇩🇪 Cologne, Germany